Occurrence and severity of side effects during use of the product in order to ensure the security of it. [ Time Frame: After drug administration, 1, 3, 7, 14, 21, 28, 35, 42, 49, 56 and 63 days after. ] [ Designated as safety issue: Yes ]

Secondly, it will be observed safety (tolerability) in clinical patients by comparing the clinical and laboratory parameters before and after the study and the incidence of adverse events after a single dose

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

- Accept the Terms of Consent;

be aged over 18, regardless of sex;

Patients with acromegaly who presented GH levels ≥ 2.5 ng / mL or no suppression of GH levels to less than 1 ng / mL after tolerance test glucose and IGF-I levels for age and sex;

Patients undergoing hypophysectomy followed by radiotherapy or not and to keep níves increased GH and IGF-I;

Patients waiting hypophysectomy with increased levels of GH and IGF-I

Exclusion Criteria:

Have participated in any experimental study or have ingested any drug trial within six months prior to the start of the study;

Have made use of medications that influence the results, regular 4 weeks prior to the start of the study or having used any medication a week before the start of the study;

Have been treated with somastostatina analog or dopamine agonist in the last 2 months;

Present history of myocardial infarction, angina and / or heart failure;

Patients who present calculation of the gallbladder and have not undergone cholecystectomy;

Pregnant women and nursing;

Patients who have allergies to medicine;

Patients with a history of acute pancreatitis;

Patient with altered levels of amylase

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086982